Human research is research conducted with or about people, or their data or tissue. The appropriate review pathway for your human research project depends on the level of risk and for multisite ethical review the number and location of sites included for review.
The following matters must be considered before submitting an ethics application.
Peter Mac has implemented a review process for clinical research in which Peter Mac is acting as the study sponsor. The sponsor of a clinical research project assumes the overall responsibility for the initiation, management (including ongoing oversight) and financing (or arranging the financing) of a study, as well as the overall scientific integrity of the data derived and results reported.
If Peter Mac will be the sponsor of a clinical research project, you must consult the Office of Cancer Research (OCR) for assistance when developing your study concept. For further information, contact the OCR: [email protected].
Note that for clinical research where Peter Mac is acting as the sponsor, approval from the Clinical Research Sponsorship Committee must be submitted to the Peter Mac Ethics Committee along with the application for ethical review.
Clinical trials that will be administering an investigational medicinal product to humans for the first time may require a First Time in Human by an expert reviewer. An expert review may be required for all or some of the following areas: Medicines; Toxicology; Immunology; Biologicals; Biologicals Biodynamics & Kinetics; Medical Devices. To assess whether or not your project requires First Time in Human review, complete the FTIH Review Required Questions. This expert review must be completed before submission of the clinical trial application to the Ethics Committee. Please consult the Human Research Ethics & Governance office for advice.
Clinical research involving the use of genetically modified organisms (GMOs) at Peter Mac may require review by the Institutional Biosafety Committee (IBC). To assess whether or not your project requires IBC review, complete the Clinical Trials Involving GMOs questionnaire and consult the Office of the Gene Technology Regulator (OGTR) “Guidance on the requirements for clinical trials involving GMOs ”. If your project requires IBC review for the Peter Mac site, this should be completed prior to submission to the Ethics Committee. For any questions regarding the IBC and for submission requirements, please contact the IBC secretary: [email protected]
The Peter MacCallum Cancer Centre Ethics Committee can provide ethical review for clinical trials and other human health and medical research projects, including low risk and negligible risk research projects, for multiple sites in Victoria, New South Wales, Queensland, South Australia, Australian Capital Territory and Western Australia under the National Mutual Acceptance scheme for:
- Interventional research for multiple public hospital sites in: Victoria (from November 2009); New South Wales and Queensland (from November 2012); South Australia (from November 2013); Australian Capital Territory (from August 2016) and Western Australia (from September 2017). IMPORTANT NOTE: New South Wales and South Australia do not accept ethical review of Phase I clinical trials under National Mutual Acceptance.
- All types of human health and medical research, including low and negligible risk research, for multiple public hospital sites in: Victoria (from February 2015); New South Wales, Queensland and South Australia (from January 2016); Australian Capital Territory (from August 2016) and Western Australia (from September 2017).
All research being ethically reviewed for sites outside of Victoria must be submitted and reviewed by the full Human Research Ethics Committee, regardless of the risk level of the project. Research being ethically reviewed for multiple sites only in Victoria may be reviewed by the full Ethics Committee or by other pathways, as appropriate to the risk level of the project.
See the HRECs RGOs and organisations participating in the National Mutual Acceptance scheme.
The Peter Mac Ethics Committee can also provide multisite ethical review for all Research Excellence (REx) partner institutions. The REx partner organisations are: Austin Health; Melbourne Health; Peter Mac; Royal Children's Hospital; St Vincent's Hospital Melbourne; Florey Institute of Neuroscience and Mental Health; Murdoch Children's Research Institute; Northern Health; Royal Women's Hospital; University of Melbourne; Walter and Eliza Hall Institute; and Western Health.
For multisite ethical review submissions the Coordinating Principal Investigator (CPI) is responsible for submitting the Ethics application on behalf of all participating sites. The Ethical Approval will be issued to the Coordinating Principal Investigator and list all eligible sites included in the ethics application. Reports required for ongoing ethical monitoring of the project for all sites e.g. amendments and annual reports, must be submitted to the reviewing HREC by the CPI or project sponsor on behalf of all sites.
Each participating site is still responsible for providing authorisation for a new project to commence at that site and for an amended project to continue at that site. The Principal Investigator (PI) at each site is responsible for submitting a governance application to the site Research Governance Office to obtain site authorisation to commence or continue. Principal Investigators will need to consult their local Research Governance Office for submission advice.
Risk is defined as a potential for harm, discomfort or inconvenience. It involves the likelihood that a harm (or discomfort or inconvenience) will occur and the severity of the harm, including its consequences. The risk may be to participants and/or to others e.g. family members, social group. Both the type of risk and the level of risk must be considered. The types of risks are well described in the National Statement on Ethical Conduct in Human Research (see Chapter 2.1, page 12).
Research with more than a low level of risk must be reviewed by the full Ethics Committee, for example, any research involving an intervention or requiring tissue/blood samples; research that could raise difficult/sensitive issues for participants and/or others; research requiring tissue or data to be sent offsite. Research with a low level of risk, for example prospective research projects involving surveys or questionnaires and research projects using existing data collections, may be reviewed by other pathways.